Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization

Phase 1

Terminated

• Conditions: Liver Neoplasms
• Interventions: Device: PET/MR; Device: PET/CT

• Registration Number: NCT01744054
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a useful tool in individualizing patient care after the radioembolization procedure. The information from a PET/MR or PET/CT scan would allow for early evaluation of the technical success of the procedure.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10-25
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Primary Completion: 2017-04-03
• Study Completion: 2017-04-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Participant must successfully complete the MRI screening form if receiving an MRI
• Participant must be scheduled to undergo radioembolization for any indication
• Participant must be ≥ 18 years of age
• Participant must be able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document

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Exclusion Criteria

• Participant must not have any contraindications to MRI scanning
• Patient must not be pregnant or breastfeeding
• If agreeing to MRI contrast, participant must not have renal insufficiency (glomerular filtration rate (GFR < 30 mL/min/1.73 m2) measured within the past 60 days
• If agreeing to MRI contrast, participant must not be on dialysis
• If agreeing to MRI contrast, participant must not have had a prior allergic reaction to gadolinium-based contrast agents
• PET/MRI or PET/CT is not able to be scheduled within 72 hours of radioembolization

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/MR or PET/CT	PET/MR	* Patients must have had radioembolization, within 72 hours of the PET/MR or PET/CT * Subjects will be asked to lie still within the scanner for up to 1.5 hours while images are acquired for the liver
PET/MR or PET/CT	PET/CT	* Patients must have had radioembolization, within 72 hours of the PET/MR or PET/CT * Subjects will be asked to lie still within the scanner for up to 1.5 hours while images are acquired for the liver

Primary Outcome Measures

Name	Time	Method
Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres	1 day (one time event for patient)	A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine any presence of extrahepatic deposition of microspheres.
Evaluate y90-PET/MRI and PET/CT for potential on reporting technical success of radioembolization	1 day (one time event for patient)	A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine whether technical success of the procedure can be determined. They will rate the images if they are 'adequate' to report on these two measures.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States